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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203415

XTANDI (ENZALUTAMIDE)
40MG
Marketing Status: Prescription
Active Ingredient: ENZALUTAMIDE
Proprietary Name: XTANDI
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N203415
Product Number: 001
Approval Date: Aug 31, 2012
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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